Study of Valproate in Young Patients Suffering From Epilepsy

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Main objective: Therapeutic follow-up study Evaluate the clinical and biological safety of valproate administered as microgranules, under standard prescription conditions, with therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations and antiepileptic comedication as well as biological assays.

Secondary objectives: Ancillary population kinetics study

• Estimate the pharmacokinetic parameters of valproate administered as microgranules under standard therapeutic conditions within the population studied, from the therapeutic follow-up data.

• Evaluate the influence of individual characteristics on the pharmacokinetic parameters.

• Describe the relationship between plasma concentrations and adverse events for valproate and the main anti-epileptic comedications.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• Children aged between 6 months and 15 years.

• Suffering from any type of epilepsy.

• Receiving at the time of inclusion valproate in the form Micropakine® SR 20 to 30 mg/kg/d by oral route, in 2 daily administrations and at most two other antiepileptic drugs (an antiepileptic benzodiazepine treatment taken daily or on demand more than 2 times weekly, must be considered as an antiepileptic treatment).

• Followed by hospital paediatricians or neuropaediatricians.

• For whom the consent has been signed by the parents or the holders of parental authority and if possible by the child him/herself.

• For whom the parents or legal guardian do not have any language or cultural obstacle for understanding the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.